QC Analyst B7 II - USA

The Fountain Group; Durham (NC); On-site; USD 37,000 - 41,000; Full time

Job summary

The Fountain Group is seeking a QC Sample Coordinator for a prominent client in Durham, NC. The role focuses on overseeing QC processes for in-process, release, raw material, stability, and development samples, with documentation and data collection.

This 7-month assignment offers $27-30/hr to start, a Monday-Friday schedule, and exposure to GMP-regulated workflows across QA, Manufacturing, and Logistics.

Qualifications

• Bachelor’s degree in a relevant scientific field with GMP QC Laboratory experience preferred.
• Associate’s degree with 4+ years GMP QC Laboratory experience, or HS diploma with 6+ years related experience may be considered.
• Strong understanding of sample receipt, inventory management, and sample tracking in a GMP laboratory.

Responsibilities

• Oversee QC in-process, release, raw material, stability, and development samples, including documentation and data collection.
• Manage sample receipt, tracking, inventory, submissions, and shipment activities in accordance with GMP requirements.
• Generate sample submission forms, process testing results, and confirm testing completion.
• Support stability studies, including sample sets, pulls, aliquoting, shipping, and temperature monitoring.
• Execute protocols supporting stability programs, qualified material programs, and pipeline product studies.
• Review incoming samples and temperature data to ensure compliance with SOPs and laboratory requirements.
• Maintain accurate records in paper-based and electronic laboratory information management systems.
• Write and revise SOPs, technical reports, and sample management procedures.
• Support investigations, audits, inspections, and corrective and preventive actions.
• Collaborate with Quality Assurance, Manufacturing, Facilities, Logistics, and other sites to address compliance issues and improve processes.
• Support employee training, task coordination, and continuous improvement activities.
• Follow all GMP, safety, quality, and regulatory requirements.

Skills

GMP QC

Technical writing

Documentation

SOPs writing

Team collaboration

Education

Bachelor’s degree in life science

Associate’s degree with GMP QC experience

High School diploma with GMP QC experience

Tools

LIMS

ELN

Job description

We are a national staffing firm and are currently seeking a QC Sample Coordinator for a prominent client of ours. This position is located in Durham, NC.Details of the position are as follows:

Job Description:

• $27-30/hr to start!
• Monday-Friday
• This position is a 7-month assignment with the possibility of extension or conversion.

Responsibilities:

• Oversee QC in-process, release, raw material, stability, and development samples, including documentation and data collection.
• Manage sample receipt, tracking, inventory, submissions, and shipment activities in accordance with GMP requirements.
• Generate sample submission forms, process testing results, and confirm testing completion.
• Support stability studies, including sample sets, pulls, aliquoting, shipping, and temperature monitoring.
• Execute protocols supporting stability programs, qualified material programs, and pipeline product studies.
• Review incoming samples and temperature data to ensure compliance with SOPs and laboratory requirements.
• Maintain accurate records in paper-based and electronic laboratory information management systems.
• Write and revise SOPs, technical reports, and sample management procedures.
• Support investigations, audits, inspections, and corrective and preventive actions.
• Collaborate with Quality Assurance, Manufacturing, Facilities, Logistics, and other sites to address compliance issues and improve processes.
• Support employee training, task coordination, and continuous improvement activities.
• Follow all GMP, safety, quality, and regulatory requirements.

Qualifications:

• Bachelor’s degree in a relevant scientific field with 2+ years of GMP Quality Control Laboratory experience preferred.
• Associate’s degree with 4+ years of relevant GMP QC Laboratory experience, or High School diploma with 6+ years of related experience, may be considered.
• Strong understanding of sample receipt, inventory management, and sample tracking in a GMP laboratory.
• Experience with stability programs, QC testing, and laboratory documentation preferred.
• Experience working with paper-based and electronic laboratory information management systems.
• Strong technical writing, documentation, and communication skills.
• Ability to work independently and effectively within a team and across departments.
• Knowledge of GMP requirements and FDA/EMEA regulations.